deltatrials
Completed OBSERVATIONAL NCT01647906

Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI) (SoFI)

A Prospective, Single Arm, Multicenter, Observational Assessment of the Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)

Sponsor: Bausch Health Americas, Inc.

Updated 10 times since 2017 Last updated: Nov 21, 2019 Started: May 31, 2012 Primary completion: Sep 15, 2018 Completion: Sep 15, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Fecal Incontinence and is currently completed. Bausch Health Americas, Inc. leads this study, which shows 10 recorded versions since 2012 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotEnrolling By Invitation~Feb 2017 – ~Dec 2017 · 10 months · monthly snapshotEnrolling By Invitation~Dec 2017 – ~Apr 2018 · 4 months · monthly snapshotActive Not Recruiting~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Jun 2019 · 12 months · monthly snapshotActive Not Recruiting~Jun 2019 – ~Dec 2019 · 6 months · monthly snapshotActive Not Recruiting~Dec 2019 – ~Jan 2021 · 13 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed

  2. Jul 2024 — Sep 2024 [monthly]

    Completed

  3. Jan 2021 — Jul 2024 [monthly]

    Completed

  4. Dec 2019 — Jan 2021 [monthly]

    Completed

    Status: Active Not RecruitingCompleted

  5. Jun 2019 — Dec 2019 [monthly]

    Active Not Recruiting

Show 5 earlier versions
  1. Jun 2018 — Jun 2019 [monthly]

    Active Not Recruiting

  2. Apr 2018 — Jun 2018 [monthly]

    Active Not Recruiting

    Phase: NANone

  3. Dec 2017 — Apr 2018 [monthly]

    Active Not Recruiting NA

    Status: Enrolling By InvitationActive Not Recruiting

  4. Feb 2017 — Dec 2017 [monthly]

    Enrolling By Invitation NA

  5. Jan 2017 — Feb 2017 [monthly]

    Enrolling By Invitation NA

    First recorded

May 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bausch Health Americas, Inc.
Data source: Bausch Health Americas, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .